OXiGENE Reports Publication of Final FACT Study Data in Journal Thyroid; Immunomedics' 90Y-Epratuzumab Study Shows Improvement of Therapy Results Print E-mail
By Staff and Wire Reports   
Monday, 10 June 2013 18:37

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 10, 2013. OXiGENE, Inc. (Nasdaq: OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer, announced the publication in the peer-reviewed journal Thyroid of the final results of a randomized controlled global trial in anaplastic thyroid cancer (ATC) which suggests a survival benefit in patients who received ZYBRESTAT and chemotherapy versus chemotherapy alone.

The results of the FACT study (Fosbretabulin in Anaplastic Cancer of the Thyroid) form the basis of the company's ongoing efforts to pursue a Marketing Application Authorization (MAA) with the European Medicine Agency (EMA) under the Exceptional Circumstances process which is specifically designated for very rare diseases that have limited or no available therapeutic options and a significant unmet medical need.

The online publication, ahead of print, titled "Randomized safety and efficacy study of fosbretabulin with paclitaxel/carboplatin against anaplastic thyroid carcinoma," by Sosa et al., is available at: http://0-www.ncbi.nlm.nih.gov.elis.tmu.edu.tw/pubmed/23721245. The preliminary results of the FACT study were previously presented as an oral presentation at American Society of Clinical Oncology (ASCO) meeting and named "Best of ASCO" in 2011.

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Immunomedics (Nasdaq: IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, reported adding two doses of epratuzumab labeled with the radioisotope, yttrium-90 (90Y), to a combination of rituximab and CHOP chemotherapy (R-CHOP), the standard of care for patients with diffuse large B-cell lymphoma (DLBCL), appeared to improve elderly patients' responses to treatment.

DLBCL is the most common type of aggressive non-Hodgkin lymphoma (NHL), with approximately 20,000 new patients diagnosed each year in the United States. Although the standard therapy for DLBCL is R-CHOP, elderly patients who fail R-CHOP have a poor outcome. Due to advanced age, chemo-resistant disease, and/or concurrent co-morbid medical conditions, a significant percentage of these patients are not eligible for high-dose salvage therapy or stem cell transplant. Consequently, there is a need for an alternative therapy for high-risk patients with a lower chance of being cured with standard R-CHOP.

Epratuzumab is a humanized antibody that binds to the CD22 receptor on B cells. In various clinical trials, epratuzumab was found to be active as an unlabeled antibody in patients with NHL or lupus. Previous clinical studies have also demonstrated that repeated administration of small doses of 90Y-epratuzumab (fractionated RAIT) produced high rates of durable responses in NHL patients.1

Results from a multicenter Phase II trial sponsored by the GOELAMS/LYSA French study group were updated by Françoise Kraeber-Bodéré, MD, PhD, Nuclear Medicine Department, Hôtel-Dieu University Hospital,, Nantes, France, in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging 2013 Annual Meeting. The objective of this study is to evaluate 90Y-epratuzumab given in multiple, small doses as consolidation therapy after R-CHOP in previously untreated elderly patients with advanced DLBCL, using 2-year event-free survival (EFS) as the primary end-point.

At the time of reporting, a total of 75 patients between the ages of 60 and 79 years had been enrolled to receive 3 cycles of R-CHOP therapy. Patients who reported a partial response or better proceeded to receive 3 additional cycles of R-CHOP, followed 6 – 8 weeks later by 2 once-a-week infusions of 90Y-epratuzumab at the 15 mCi/m2 dose level. In all, 61 patients were eligible for the radioimmunotherapy (RIT) with 90Y-epratuzumab.


Also Monday:

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialised in research, development and commercialisation of protein kinase inhibitors (PKI), issued to existing shareholders 2 bond loan agreements, convertible or repayable in ordinary shares, for the nominal amount of 12,508,268 euros in a private arrangement.

Abbott (NYSE: ABT)
will present at the Wells Fargo Securities Research & Economics 2013 Healthcare Conference on Wednesday, June 19, 2013.

Andain Inc. (OTCBB: ANDN)
("Andain"), a company engaged in commercializing novel technologies in the fields of biotech, medical and life sciences through its accelerating incubator program, announced today the production of 2,000 miniature disposable insulin pump units for clinical trials.

Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the Keynote Address at the BWH Regenerative Medicine Center Inaugural Symposium, being held at Brigham & Women’s Hospital in Boston on June 11.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, today announced its support for Are You Dense, Inc., an independent, national breast health advocacy organization dedicated to informing the public about dense breast tissue and its significance for the early detection of breast cancer.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI)
announced today that it engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BUNAVAIL for the maintenance treatment of opioid dependence.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, announced today that, its board of directors (the "Board") has increased its size from four to six members and, effective June 7, 2013, appointed Frederic H. Moll, M.D. and Erin S. Enright to the Board.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that it has signed an out-licensing agreement with Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), the leading Chinese pharmaceutical company in the liver disease therapeutic area, for the development and commercialization of BL-8030, an orally available treatment for the Hepatitis C virus (HCV).

China Biologic Products, Inc. (Nasdaq: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company has waived the application of its Preferred Shares Rights Agreement dated as of November 20, 2012 (the "Rights Agreement") to the RAAS SPA (as defined below).

eHealth, Inc (NASDAQ: EHTH)
, parent company of eHealthInsurance.com, America's first and largest private online health insurance exchange, published the second step in its six step guide to help consumers prepare for health care reform and this year's new open enrollment period, which begins Oct. 1, 2013.

EncounterCare Solutions (PINKSHEETS: ECSL)
announced today that its subsidiary, CyberCare Health Network, Inc. ("CyberCare HN"), has initiated the launch of its new GPS tracking system called CyberTrax.

Exact Sciences Corp. (Nasdaq: EXAS)
today announced that it has submitted to the U.S. Food and Drug Administration the final module of the premarket approval (PMA) application for Cologuard™, the company’s stool DNA (sDNA) colorectal cancer screening test.

Latteno Food Corp. (PINKSHEETS: LATF)
, through its subsidiaries, is focused on operating within the food and beverage industries.

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME)
, a developer of tissue fluorescence visualization technologies for the medical industry, is pleased to announce that its patented VELscope® Vx oral examination device is currently involved in a Phase III study sponsored by the University of British Columbia in collaboration with the Terry Fox Research Institute and the British Columbia Cancer Agency.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR") today announced that through its China Joint Venture, Unis-Tonghe MMR International Health Management Service Co., Ltd., with JV partner Unis-Tonghe Technology (Zhengzhou) Co., Ltd. ("UNIS"), the Company is participating in the Chinese government's building of health information technology systems that will, among other things, exchange Electronic Medical Records (EMRs) data to Personal Health Records (PHRs).

Metabolix, Inc. (NASDAQ: MBLX)
, an innovation-driven bioscience company focused on delivering sustainable solutions for plastics, chemicals and energy, today announced that its executives will be presenting at two leading industry conferences in June.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that a randomized controlled trial (RCT) for the Company's EpiFix® wound care allograft has been published in the International Wound Journal.

Neogen Corporation (Nasdaq: NEOG)
announced today that Lon Bohannon, the company's President and Chief Operating Officer, has announced his intent to retire effective August 31, 2013.

Nutra Pharma Corporation (OTCQB: NPHC)
, a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that the Company has entered into a licensing agreement with Cobra Pharmaceuticals for the re-launch of their all-natural, non-addictive pain reliever - Cobroxin®, the first OTC pain reliever clinically proven to treat Stage 2 (moderate to severe) chronic pain.

Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes that the rare combination of large early stage investments in its pancreatic cancer R&D program and its Phase II clinical trial performance strongly bolsters Nuvilex's (OTCQB: NVLX) prospects for approval of its treatment for advanced inoperable pancreatic cancer.

PowerSafe Technology Corporation (PINKSHEETS: PSFT)
announced that on May 14th its wholly owned subsidiary Amplification Technologies Inc. (ATI) (www.ampti.co) was awarded U.S. Patent # 8,441,032 titled "Low level Signal Detection by Semiconductor Avalanche Amplification."

Seattle Genetics, Inc. (Nasdaq:SGEN)
today announced the initiation of a phase 1/2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with bendamustine for patients with Hodgkin lymphoma (HL) after first relapse.

Synergetics USA, Inc. (NASDAQ: SURG)
, a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, today announced results for the third quarter ended April 30, 2013.

Z Trim Holdings, Inc. (OTC: ZTHO)
, a biotechnology company providing value-added ingredients to a variety of industries, today announced that it will be presenting at this year's Clean Label Conference held by Global Food Forums, to show how Z Trim ingredients can help manufacturer's replace chemically modified foods with Z Trim Corn Fiber.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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